Pneumonia
Conditions
Keywords
Oral care, Vaccine, Pneumonia, Elderly, Prevention, Primary care
Brief summary
Prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia.
Detailed description
The elderly population can be expected to increase not only in developed countries, but also in developing countries. Pneumonia is one of the most common causes of death in the elderly. The investigators conducted a prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia in consecutive elderly patients at a nursing home in Yubari during one year from 2009, with the results in a non-intervention group.
Interventions
BIOLOGICALPneumococcal vaccination (Pneumovax NP, 21800AMY10131000)
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
BIOLOGICALInfluenza vaccination (Flubik HA, 16100EZZ01207000)
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
OTHERSpecific frequency of oral care
1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room primary care physicians. At the same time, they taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material.
Sponsors
Health Research Foundation
Yubari Kibounomori
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* The residents or an agent who understand the purpose of this study and give informed consent.
Exclusion criteria
* The residents contraindicated to vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pneumonia | 1 year | Number of Participants with Pneumonia sufferers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death From Pneumonia | 1 year | Number of participants for the death from pneumonia |
Other
| Measure | Time frame | Description |
|---|---|---|
| Leaving Nursing Home | These participants were followed for the duration of nursing home stay, an average of 22 weeks. | Numer of resident for leaving nursing home |
| Reject Oral Care | This participant rejected oral care before treatment, Day 1 | Number of resident to reject oral care |
| Reject Vaccine | These participants rejected vaccine before treatment, Day 1 | Number of resident to reject vaccine |
| Died Before Oral Care Starting | This participant was died before treatment, Day 1 | Number of resident died before the start of oral care |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Influenza Vaccine Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.). | 94 |
| Oral Care With Influenza and Pneumococcal Vaccines Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;
1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material. | 105 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Oral Care With Influenza and Pneumococcal Vaccines | Influenza Vaccine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 105 Participants | 92 Participants | 197 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants |
| Age Continuous | 86.0 years STANDARD_DEVIATION 7.64 | 85.0 years STANDARD_DEVIATION 7.48 | 85.5 years STANDARD_DEVIATION 7.56 |
| Region of Enrollment Japan | 105 participants | 94 participants | 199 participants |
| Sex: Female, Male Female | 77 Participants | 66 Participants | 143 Participants |
| Sex: Female, Male Male | 28 Participants | 28 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 94 | 0 / 105 |
| serious Total, serious adverse events | 8 / 94 | 2 / 105 |
Outcome results
Primary
Number of Participants With Pneumonia
Number of Participants with Pneumonia sufferers
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Influenza Vaccine | Number of Participants With Pneumonia | 21 participants |
| Oral Care With Influenza and Pneumococcal Vaccines | Number of Participants With Pneumonia | 2 participants |
Comparison: The results were analyzed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.p-value: <0.001Fisher Exact
Secondary
Death From Pneumonia
Number of participants for the death from pneumonia
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Influenza Vaccine | Death From Pneumonia | 8 participants |
| Oral Care With Influenza and Pneumococcal Vaccines | Death From Pneumonia | 1 participants |
Comparison: The results are expressed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.p-value: 0.05Fisher Exact
Other Pre-specified
Died Before Oral Care Starting
Number of resident died before the start of oral care
Time frame: This participant was died before treatment, Day 1
Population: This participant was determined as Not Completed due to Died before oral care starting. We excluded this participant from analysis for outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Influenza Vaccine | Died Before Oral Care Starting | 1 participants |
Other Pre-specified
Leaving Nursing Home
Numer of resident for leaving nursing home
Time frame: These participants were followed for the duration of nursing home stay, an average of 22 weeks.
Population: These participants were determined as Not Completed due to Leaving nursing home. We excluded these participants from analysis for outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Influenza Vaccine | Leaving Nursing Home | 2 participants |
Other Pre-specified
Reject Oral Care
Number of resident to reject oral care
Time frame: This participant rejected oral care before treatment, Day 1
Population: This participant was determined as Not Completed due to Reject oral care. We excluded this participant from analysis for outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Influenza Vaccine | Reject Oral Care | 1 participants |
Other Pre-specified
Reject Vaccine
Number of resident to reject vaccine
Time frame: These participants rejected vaccine before treatment, Day 1
Population: These participants were determined as Not Completed due to Reject vaccine. We excluded these participants from analysis for outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Influenza Vaccine | Reject Vaccine | 3 participants |